Laparoscopic Gastric Band With Active Agents

ABSTRACT

A gastric banding system is provided which generally includes a gastric band and an active agent, for example, a metabolic agent or satiety inducing agent. The band may be structured to contain the agent and permit controlled release of the agent to the patient while the band is positioned around the stomach. Methods for treating obesity are also provided which include positioning a gastric band on the stomach of a patient and administering a satiety inducing agent to the patient while the gastric band is positioned on the stomach.

RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/174,874, filed on May 1, 2009, the entire disclosure of which isincorporated herein by this specific reference.

BACKGROUND

The present invention relates to laparoscopic gastric banding fortreatment of obesity and obesity related disorders and more specificallyrelates to a laparoscopic gastric band system including active agents.

Laparoscopic adjustable gastric bands have a successful history ofinducing weight loss in obese patients. The band is secured around thestomach just below the gastroesophogeal junction. This creates a smallpouch above the band which can only accept a small volume of food.Generally, this allows the patient to ingest only a small amount of foodbefore the patient begins to feel satiated and full, and consequently,the patient is less likely to eat to excess. With reduced caloricintake, the patient loses weight. It is known that some patients,however, reach a “plateau” in their rate of weight loss over time, evenwith the gastric band in place.

Despite the relative safety and success of gastric banding in treatingobesity and obesity related conditions, there remains a need forimproved systems and methods for treating obesity and obesity relatedconditions in some patients.

SUMMARY OF THE INVENTION

The present invention provides a gastric banding system generallycomprising a gastric band structured to be placed around the stomach ofa patient. Further, the band is capable of dispensing an active agent,for example, a metabolic agent, for example, but not limited to, asatiety inducing agent, to the patient while the band is positionedaround the stomach. The system may provide more effective obesitytreatment relative to obesity treatment using a gastric band alone.

For example, the system may further comprise a metabolic agent, or asatiety inducing agent, for being dispensed to the patient while theband is positioned around the stomach. The satiety inducing agent may beincorporated into the gastric band.

In one embodiment, an ancillary device is incorporated into the gastricband and the ancillary device includes, or is capable of dispensing tothe patient, a satiety inducing agent. The ancillary device may bestructured to provide controlled release of the satiety inducing agentto the patient.

For example, the ancillary device comprises a membrane or film permeableto a satiety inducing agent. The agent may be covered or enclosed by themembrane and is released into the body by diffusion through themembrane.

In other embodiments, the ancillary device may comprise a compositionincluding a matrix material and a satiety inducing agent combined withthe matrix material. The matrix material may be a bioerodible material,for example a bioerodible polymer which, during erosion thereof in thebody, releases the agent from the composition in a controlled manner.

Alternatively, the ancillary device may be a non-bioerodible material.The device may include structures for containing and releasing thesatiety inducing agents, for example in a controlled manner. In oneembodiment, the ancillary device includes recessions, pores or groovescapable of containing a satiety inducing agent.

In some embodiments of the invention, the satiety inducing agent is ahormone, for example a peptide hormone. The peptide hormone may be atleast one agent selected from the group consisting of Glucagon-likepeptide (GLP-1), Oxyntomodulin (OXM), Peptide YY (PYY), PancreaticPolypeptide (PP), Insulin, Leptin, Gastrin, Ghrelin blocker, aninhibitors of DPP-IV, and Amylin. The satiety inducing agent may beCholecystokinin (CCK).

In other embodiments the ancillary device further includes a film ormembrane in contact with the agent and capable of releasing the agentfrom the ancillary device and into the patient, for example, at acontrolled rate.

In some embodiments, the gastric band itself is structured to be capableof releasing a satiety inducing agent into the patient at a controlledrate.

The present invention further provides a method of treating obesity oran obesity related condition in a patient. In one embodiment, the methodcomprises implanting a gastric band in a patient and providing acomposition effective to induce satiety in the patient wherein thecomposition is positioned between the gastric band and the stomach ofthe patient when the gastric band is so positioned around the stomach ofthe patient.

For example, the composition may comprise composition as describedelsewhere herein. For example, the composition may include a satietyinducing agent and a bioerodible material combined with the agentwherein the agent is distributed in the bioerodible material and iseffective, when released into the patient, to at least assist ininducing satiety in the patient.

In another aspect of the invention, a method for treating obesity or anobesity related condition is provided wherein the method comprisespositioning a gastric band on the stomach of a patient and administeringa satiety inducing agent to the patient while the gastric band ispositioned on the stomach.

The step of administering may comprise dispensing the agent to one ofthe stomach, intestine, peritoneum, intra-peritoneal cavity, and abdomenof the patient. In other embodiments, the agent is administeredsubcutaneously to the patient. In yet other embodiments, the step ofadministering comprises administering the agent directly to the centralnervous system. In yet other embodiments, the agent is administered asan inhalant.

The step of administering may further comprise controlling a rate ofrelease of the agent into the patient.

The agent may be administered at a controlled rate over a period of atleast about six months, or at least about one year or at least aboutthree years. In some embodiments, the controlled rate includes a periodof dosage tapering, or a period of dosage increasing.

It is to be appreciated that the active agents useful in the presentinvention are not limited to satiety inducing agents but may alsoinclude any active agents, for example, other metabolic agents, that mayprovide some benefit to a patient suffering from obesity and/or obesityrelated conditions.

Each and every feature described herein, and each and every combinationof two or more of such features, is included within the scope of thepresent invention provided that the features included in such acombination are not mutually inconsistent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a system for treating obesity andobesity related conditions, in accordance with the invention.

FIGS. 2A and 2B are perspective views of surface structures useful forcontaining active agents in conjunction with a gastric band, inaccordance with systems of the present invention.

FIG. 3 is a simplified representation of a diffusion material useful forcontrolling release of active agents in conjunction with a gastric band,in accordance with systems of the present invention.

DETAILED DESCRIPTION

Turning now to FIG. 1, the present invention provides a gastric bandsystem 10 which is structured to dispense an active agent, for example,a metabolic agent, for example a satiety inducing agent, for example, asatiety gut hormone or bioactive molecule, into the body. Although thepresent disclosure will typically be discussing, specifically, satietyinducing agents, it is to be appreciated that the present invention isnot limited to active agents that are, specifically, satiety inducingagents. Active agents useful with the present invention are intended toinclude other compositions, drugs or other agents, for example, agentsthat affect body metabolism without necessarily affecting satiety, thatare believed to be effective, at least to some degree, in facilitatingweight loss in a human being.

In an exemplary embodiment, the system 10 generally comprises a gastricband 12 which is structured to be placed at the stomach 2 of a patientin such a manner so as to form a stoma 4, or pouch. The gastric band 12may be an inflatable hydraulic gastric band (such as shown) or amechanically adjustable gastric band. The gastric band 12 may include astoma adjustment mechanism 14, comprising, for example, a fill line 16and an implantable access port 18. By injecting or withdrawing a fillingfluid from access port 18, for example, through the use of aneedle/syringe 8, a physician can adjust a level of restriction of theband 12.

Further, the system 10 is capable of dispensing an active agent, forexample, but not limited to, a satiety inducing agent, to the patientwhile the band is positioned around the stomach 2. The system 10 mayprovide more effective obesity treatment relative to obesity treatmentusing a gastric band alone.

For example, the system 10 may further comprise an active agent forbeing dispensed to the patient while the gastric band 12 is positionedat the stomach 2. The active agent may be incorporated into the gastricband.

In some embodiments, system further comprises an ancillary device 22capable of dispensing to the patient, an active agent, while the system10 is implanted in the patient. The ancillary device 22 may beincorporated into the gastric band 12, for example, at a region of theband 12 in contact with the stomach 2.

In some embodiments, the ancillary device comprises a compositionincorporated into the gastric band. The composition may comprise amatrix material and an active agent, such as a satiety inducing agent,combined with the matrix material. The matrix material may be abioerodible material, for example a bioerodible polymer which, duringerosion thereof in the body, releases the agent from the composition,for example, in a controlled manner, for example in a time-releasefashion.

Alternatively, the ancillary device may comprise a non-bioerodiblematerial structured to facilitate release of an active agent into thebody. In some embodiments, the device includes include structures forcontaining and releasing active agents, for example, in a controlledmanner. Combinations of bioerodible and non-bioerodible materials forcontaining and releasing active agents are also contemplated.

In one embodiment, the ancillary device includes recessions, pores orgrooves capable of containing an agent.

For example, an ancillary device 122, useful in the present systems, isshown FIG. 2A. Device 122 may include one or more of the features ofancillary device 22 described elsewhere herein.

Ancillary device 122 comprises a polymer surface having one or moreindentations or grooves 24 capable of containing or holding a satietyinducing agent, or a composition containing a satiety inducing agent,for example, in solid, gel, powder, paste or other form.

Turning now to FIG. 2B, alternatively or additionally, the ancillarydevice 222 comprises a polymer surface having a porous or otherirregular structure, wherein pores 28 are capable of containing orholding an agent, or a composition such as a matrix material containingan agent.

Ancillary device 22, 122, 222 may be made of any suitable, biocompatiblematerial, for example, any suitable material approved by the Food andDrug Administration (FDA) for use in humans, for example, as approvedfor long term administration of agents. In one embodiment, the materialis ethylene vinyl acetate (EVA).

In some embodiments, the active agent is a satiety inducing agent, forexample, a hormone, for example a peptide hormone. The peptide hormonemay be at least one agent selected from the group consisting ofGlucagon-like peptide (GLP-1), Oxyntomodulin (OXM), Peptide YY (PYY),Pancreatic Polypeptide (PP), Insulin, Leptin, Gastrin, Ghrelin blocker,an inhibitors of DPP-IV, and Amylin. The satiety inducing agent may beCholecystokinin (CCK).

In some embodiments of the invention, the active agent is an agentselected from a list of agents consisting of Glial-Derived NeurotrophicFactor (GDNF); Serotonin; Dopamine and its Analogues such as: Ibogaine,Noribogaine, 18-MC, and Cabergoline; Ciliary-derived Neurotrophic Factor(CNTF); Cocain-Amphetamine Regulated Transcript (CART); Serotonin andits Analogues; Gastric Inhibitory Peptide or Glucose-dependantInsulinotropic Peptide (GIP); Neuropeptide Y receptor antagonists andiRNA/siRNA; Orexin A receptor antagonists and iRNA/siRNA; Agouti RelatedPeptide (AgRP) receptor antagonists and iRNA/siRNA; Cannabanoid receptorantagonists and iRNA/siRNA; and the Melanocortins: Pro-Opiomelanocortin,Melanocyte Stimulating Hormone; Melanin Concentrating Hormone (MCH)receptor antagonists and iRNA/siRNA.

Discussions of gastrointestinal hormones that control appetite can befound in Chaudhri. O. B., Wynne, K., and Bloom, S. R. 2008. Can guthormones control appetite and prevent obesity?. Diabetes Care 31 (Suppl.2): s284-s289 and Cummings, D. E. and Overduin, J. 2007.Gastrointestinal regulation of food intake. J. Clin. Invest. 117: 13-23,the entire disclosures of which are incorporated herein by reference.

In other embodiments of the invention, the active agent may be anysuitable active agent that will improve the weight-loss effect of thegastric band. For example, the active agent may be an agent that affectsmetabolism of a patient independently of the effect, if any, on satietyof the patient. Metabolic agents that are known or suspected to have apositive effect on weight loss are known to those of skill in the art.

Referring now as well to FIG. 3, in some embodiments of the invention,the ancillary device 22 comprises a film or membrane 322 which makes upa surface of the gastric band 12, for example, a surface of the bandwhich contacts the stomach when the band is appropriately positioned. Inone embodiment, the film 322 forms at least a portion of an innercircumferential surface of the gastric band 12. The film is capable ofreleasing a satiety inducing agent from the band and into the patient,for example, at a controlled rate.

For example, the film 322 may comprise a first membrane layer 34 and asecond membrane layer 36. The film 322 may further comprise acomposition containing a satiety inducing agent, wherein the compositionis located adjacent, for example, between the first and second membranelayers 34, 36. The first and second membrane layers 34, 36 may compriseEVA or other suitable polymer or copolymer.

In the shown embodiment, the film 322 further comprises first and secondagent layers 38, 40 which are made up of a composition containing asatiety inducing agent. The first and second agent layers 38, 40 aredisposed in an alternating fashion with respect to the first and secondmembrane layers 34, 36. The membrane layers 34, 36 may have a knowndiffusion rate relative to the selected satiety inducing agent.

The film 322 is effective to control dosage and delivery of the agentsto the patient. The film 322 may therefore have a desired porosityand/or be made of a suitable material so as to provide a controlledrelease of the agent.

For example, each of the ancillary devices described herein, forexample, devices 122, 222 and 322, may be structured to provideeffective concentrations of the agent for about six months, or for aboutone year, about two years, or about three years or more. In someembodiments, the devices 122, 222, 322 are structured to provide asustained release rate, for example, of three years followed by agradually decreasing release rate over the next about two to about threeyears. Numerous release protocols are contemplated by the inventors, andare understood to fall within the scope of the present invention.

The present invention further provides a method of treating obesity oran obesity related condition in a patient. In one embodiment, the methodcomprises implanting a gastric band in a patient and providing acomposition effective to induce satiety in the patient wherein thecomposition is positioned between the gastric band and the stomach ofthe patient when the gastric band is so positioned around the stomach ofthe patient.

For example, the composition may comprise a composition as describedelsewhere herein. For example, the composition may include a satietyinducing agent and a bioerodible material combined with the agentwherein the agent is distributed in the bioerodible material and iseffective, when released into the patient, to at least assist ininducing satiety in the patient.

In another aspect of the invention, a method for treating obesity or anobesity related condition is provided wherein the method comprisespositioning a gastric band on the stomach of a patient and administeringa satiety inducing agent to the patient while the gastric band ispositioned on the stomach.

The step of administering may comprise dispensing the agent to one ofthe stomach, intestine, peritoneum, intra-peritoneal cavity, and abdomenof the patient. In other embodiments, the agent is administeredsubcutaneously to the patient. In yet other embodiments, the step ofadministering comprises administering the agent directly to the centralnervous system. In yet other embodiments, the agent is administered asan inhalant.

The step of administering may further comprise controlling a rate ofrelease of the agent into the patient.

The agent may be administered at a controlled rate over a period of atleast about six months, or at least about one year or at least aboutthree years. In some embodiments, the controlled rate includes a periodof dosage tapering, or a period of dosage increasing.

Exemplary peptide hormones which, alone or in combination, can be usedin accordance with the invention include Glucagon-like peptide (GLP-1),Oxyntomodulin (OXM), Peptide YY (PYY), Pancreatic Polypeptide (PP),Amylin, Leptin, Gastrin or Ghrelin blocker. Another hormone thatsuppresses appetite when administered with or without gastric distensionis Cholecystokinin (CCK), and other brain-gut satiety hormones such asPro-opiomelanocortin (POMC).

In the publication, “Can Gut Hormones Control Appetite and PreventObesity?” by Chaudhri, et al, research conducted on Gherlin, GLP-1,Oxyntomodulin, Inhibitors of DPP-IV, Amylin, Peptide YY, and PancreaticPolypeptide to control appetite, are described. These as well as otherhormones may be useful in accordance with the present invention.Similarly, “Gastrointestinal Regulation of Food Intake” by David E.Cummings et al describes the efficacy of satiety hormones to boostweight loss.

The agent could also be applied to the band via a slow release drugeluting coating similar to coatings used on cardiovascular stents suchas the Cordis Sirolimus Drug eluting stent or the contraceptive deviceNorplant. The coating could be applied directly to the band 12 for aslow release of the drug into the body.

An alternate method for dispensing the agent includes the provision of asemi-permeable membrane such as silicone or a nanostructure membrane aspart of other implanted components of the system 10, for example, thefluid line 16 and/or access port 18. This would allow for a slow, forexample, constant, diffusion of the agent into the body from otherlocations in the body.

Example of GLP-1

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingglucagon like peptide 1 (GLP-1) that is released at a rate to achieveplasma concentrations of [10-30 pMol/L]_(p) GLP-1 over a period of 3-24months. The patient reports a marked suppression of appetite, and within12 months, the patient has lost 58 pounds.

Example of OXM

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingoxyntomodulin (OXM) that is released at a rate to achieve plasmaconcentrations of [105-150 pMol/L]_(p) OXM over a period of 3-24 months.The patient reports a marked suppression of appetite, and within 12months, the patient has lost 58 pounds.

Example of PYY

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingPeptide Y-Y (PYY) that is released at a rate to achieve plasmaconcentrations of [10-55 pMol/L]_(p) PYY over a period of 3-24 months.The patient reports a marked suppression of appetite, and within 12months, the patient has lost 58 pounds.

Example of PP

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingPancreatic Peptide (PP) that is released at a rate to achieve plasmaconcentrations of [150-300 pMol/L]_(p) PP over a period of 3-24 months.The patient reports a marked suppression of appetite, and within 12months, the patient has lost 58 pounds.

Example of Insulin

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingInsulin that is released at a rate to achieve plasma concentrations of[5-30 μU/mL]_(p) Insulin over a period of 3-24 months. The patientreports a marked suppression of appetite, and within 12 months, thepatient has lost 58 pounds.

Example of Leptin

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingLeptin that is released at a rate to achieve plasma concentrations of*[3-10 ng/mL]_(p) Leptin over a period of 3-24 months. The patientreports a marked suppression of appetite, and within 12 months, thepatient has lost 58 pounds. *In the case of a female patient the goalplasma concentrations would be [10-20 ng/mL]_(p).

Example of Amylin

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingAmylin that is released at a rate to achieve plasma concentrations of[20-25 pMol/L]_(p) Amylin over a period of 3-24 months. The patientreports a marked suppression of appetite, and within 12 months, thepatient has lost 58 pounds.

Example of CCK

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingCholecystokinin (CCK) that is released at a rate to achieve plasmaconcentrations of [5-10 pMol/L]_(p) CCK over a period of 3-24 months.The patient reports a marked suppression of appetite, and within 12months, the patient has lost 58 pounds.

Example of CNTF

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingCiliary neuro-trophic factor (CNTF) that is released at a rate toachieve plasma concentrations of [25-1300 pg/dL]_(p) CNTF over a periodof 3-24 months. The patient reports a marked suppression of appetite,and within 12 months, the patient has lost 58 pounds.

Example of CART

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containingCocaine-Amphetamine Regulated Transcript (CART) that is released at arate to achieve plasma concentrations of [50-250 pM]_(p) CART over aperiod of 3-24 months. The patient reports a marked suppression ofappetite, and within 12 months, the patient has lost 58 pounds.

Example of Ghrelin Inhibition/Antagonism

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containing adrug that is released at a rate to achieve plasma concentrations ofGhrelin at [15-30 pg/mL]_(p) over a period of 3-24 months. The patientreports a marked suppression of appetite, and within 12 months, thepatient has lost 58 pounds.

Example of NPY Inhibition/Antagonism

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containing adrug that is released at a rate to achieve plasma concentrations ofNeuro-peptide Y (NPY) at [65-95 pMol/L]_(p) over a period of 3-24months. The patient reports a marked suppression of appetite, and within12 months, the patient has lost 58 pounds.

Example of Orexin A Inhibition/Antagonism

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containing adrug that is released at a rate to achieve plasma concentrations ofOrexin A at [20-50 pg/mL]_(p) over a period of 3-24 months. The patientreports a marked suppression of appetite, and within 12 months, thepatient has lost 58 pounds.

Example of AgRP Inhibition/Antagonism

A 49 year old male patient, having a body weight of 322 pounds and aheight of 5′11″, complains to his physician that he has triedunsuccessfully to lose weight over the past 15 years and is concernedabout the effect his excess weight may have on his health. At thephysician's directive, the patient undergoes laparoscopic gastricbanding surgery and has implanted around the upper part of his stomach agastric band having a porous stomach-contacting surface, or a gastricband having a slowly drug eluting membrane, or a gastric band having adissolvable film, or a gastric band with small grooves, containing adrug that is released at a rate to achieve plasma concentrations of AgRPat [1-16 ng/dL]_(p) over a period of 3-24 months. The patient reports amarked suppression of appetite, and within 12 months, the patient haslost 58 pounds.

Each of the publications cited in this application is incorporatedherein in its entirety by this specific reference.

Although the invention has been described and illustrated with a certaindegree of particularity, it is to be understood that the presentdisclosure has been made only by way of example, and that numerouschanges in the combination and arrangement of parts can be resorted toby those skilled in the art without departing from the scope of theinvention, as hereinafter claimed.

1. A gastric banding system comprising: a gastric band structured to beplaced around the stomach of a patient and the band being structured tobe capable of dispensing an active agent to the patient while the bandis positioned around the stomach.
 2. The system of claim 1 furthercomprising an active agent for being dispensed to the patient while theband is positioned around the stomach.
 3. The system of claim 1 furthercomprising a satiety inducing agent incorporated into the gastric band.4. The system of claim 3 wherein the satiety inducing agent is ahormone.
 5. The system of claim 3 wherein the satiety inducing agent isa peptide hormone.
 6. The system of claim 5 wherein the peptide hormoneis an agent selected from the group consisting of Glucagon-like peptide(GLP-1), Oxyntomodulin (OXM), Peptide YY (PYY), Pancreatic Polypeptide(PP), Insulin, Leptin, Gastrin, Ghrelin blocker, an inhibitors ofDPP-IV, and Amylin.
 7. The system of claim 3 wherein the satietyinducing agent is Cholecystokinin (CCK).
 8. The system of claim 1further comprising an ancillary device incorporated into the gastricband and capable of dispensing an active agent to the patient.
 9. Thesystem of claim 8 wherein the ancillary device is structured to providecontrolled release of an active agent to the patient.
 10. The system ofclaim 8 wherein the ancillary device comprises a membrane or filmpermeable to an active agent.
 11. The system of claim 8 wherein theancillary device includes grooves capable of containing an active agent.12. The system of claim 8 wherein the ancillary device includes porescapable of containing an active agent.
 13. The system of claim 8 whereinthe ancillary device includes an active agent.
 14. The system of claim13 wherein the active agent is a satiety inducing agent.
 15. The systemof claim 13 wherein the ancillary device further includes a film ormembrane in contact with the agent and capable of releasing the agentfrom the ancillary device and into the patient.
 16. The system of claim8 wherein the ancillary device comprises a film or membrane capable ofreleasing a satiety inducing agent from the ancillary device and intothe patient at a controlled rate.
 17. The system of claim 8 wherein theancillary device is structured to be capable of releasing a satietyinducing agent into the patient at a controlled rate.
 18. The system ofclaim 1 wherein the band is structured to be capable of releasing asatiety inducing agent into the patient at a controlled rate.
 19. Amethod of inducing weight loss in a patient, the method comprisingimplanting a gastric band device in a patient; and providing acomposition, the composition comprising an active agent effective toinduce weight loss and a bioerodible material combined with the agent,the agent being distributed in the bioerodible material and beingeffective, when released into the patient, to at least assist ininducing weight loss in the patient; the composition being positionedbetween the gastric band and the stomach of the patient when the gastricband is positioned around the stomach of the patient.
 20. The method ofclaim 18 wherein the agent is an agent selected from the groupconsisting of Glucagon-like peptide (GLP-1), Oxyntomodulin (OXM),Peptide YY (PYY), Pancreatic Polypeptide (PP), Insulin, Leptin, Gastrin,Ghrelin blocker, an inhibitors of DPP-IV, and Amylin.
 21. The method ofclaim 18 wherein the bioerodible material is capable of releasing theagent into the patient at a controlled rate.
 22. A method of treatingobesity or an obesity related condition comprising: positioning agastric band on the stomach of a patient; and administering a satietyinducing agent to the patient while the gastric band is positioned onthe stomach.
 23. The method of claim 22 wherein the step ofadministering comprises dispensing the agent to one of the stomach,intestine, peritoneum, intra-peritoneal cavity, and abdomen of thepatient.
 24. The method of claim 22 wherein the step of administeringcomprises administering the agent subcutaneously to the patient.
 25. Themethod of claim 22 wherein the step of administering comprisesadministering the agent directly to the central nervous system.
 26. Themethod of claim 22 wherein the agent is administered as an inhalant. 27.The method of claim 22 wherein the step of administering comprisescontrolling a rate of release of the agent into the patient.
 28. Themethod of claim 22 wherein the agent is selected from the groupconsisting of Glucagon-like peptide (GLP-1), Oxyntomodulin (OXM),Peptide YY (PYY), Pancreatic Polypeptide (PP), Insulin, Leptin, Gastrin,Ghrelin blocker, an inhibitors of DPP-IV, and Amylin.
 29. The method ofclaim 22 wherein the step of administering comprises administering theagent at a controlled rate over a period of at least about six months.30. The method of claim 22 wherein the step of administering comprisesadministering the agent at a controlled rate over a period of at leastabout one year.
 31. The method of claim 22 wherein the step ofadministering comprises administering the agent at a controlled rateover a period of at least about three years.
 32. The method of claim 22wherein the step of administering comprises administering the agent at acontrolled rate over a period of between about six months and aboutthree years, the controlled rate including a period of dosage tapering.